Write-up: Case received from a physician on 09-Apr-2013 via the local site Sanofi Pasteur. Case medically confirmed. An adolescent patient had received the second dose of GARDASIL (batch number not reported) on an unspecified date and some time after vaccination the patient experienced demyelinating neuropathy - Guillain-Barre syndrome. There was no information about how the first dose had been tolerated. At the time of reporting, the outcome was unknown. Additional information received on 15 and 16-Apr-2013: The patient was a 13-year-old female. She was healthy apart from respiratory allergy. She was administered the third dose of GARDASIL (batch number H004182) subcutaneously on 16-Jan-2013 and 2 weeks post vaccination she started to complain of sensitivity disturbance, bilateral hyperesthesia and paresthesia of lower limbs distally, slight paresis and later of lack of strength in the distal lower limbs. The sensitive-motor symptoms progressed upwards and areflexia was reported. About 2 months after onset the patient was seen for the first time during a neurological medical visit in hospital. An EMG test was performed and confirmed demyelinating sensory-motor neuropathy. The patient was hospitalised a few days later for I.V. gamma globulin treatment in the day hospital for 5 consecutive days. This took place 2 weeks before report. At the time of reporting, the patient condition seemed to be improving. An investigation to identify other aetiology for CIDP was conducted and the results were negative. At the time of reporting, the outcome was recovering.

Write-up: Case was received from the Health Authorities on 15-Apr-2013 (reference no. PEI2013020190). Case is medically confirmed. A 13-year-old female patient received a second dose of GARDASIL (lot-no. H013132) IM into the left deltoid muscle on 29-Oct-2012. 8 days later, on 06-NOV-2012, she presented with acute rhabdomyolysis with extreme CK elevation (11046 U/I) and back pain of the thoracolumbar area. C-reactive protein was negative. Differential blood count showed normal results and carnitine deficiency was excluded. Differential diagnosis of para-infectious myositis was established, but no extensive investigation was performed to confirm this. The patient received unspecified outpatient treatment and recovered within 7-10 days. First dose of GARDASIL, lot-no. H008259, was given on 30-Aug-2012, toleration as not reported. According to the reporter, relation of the reaction to the vaccine was unlikely. Upon medical review the company judged to code infectious myositis, which was mentioned in the PV-form to local Health Authorities, but not coded by HA.

Write-up: This case was reported by a health professional via a regulatory authority (#ES-AGEMED-826410241) and described the occurrence of bradycardia in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 5 April 2013, the subject received unspecified dose of CERVARIX (unknown route and injection site). On 5 April 2013, 30 minutes after vaccination with CERVARIX, the subject experienced bradycardia, hypotension, feeling hot and headache. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with fluid therapy (unspecified). At the time of reporting the events were resolved. The vaccination course with CERVARIX was discontinued. The regulatory authority reported that the events were probably related to vaccination with CERVARIX.

Write-up: This spontaneous report as received from a physician via a sales representative refers to a 13 year old female patient. On 27-MAR-2013 the patient was vaccinated with the first dose of SILGARD (lot number not provided), intramuscular. On 30-MAR-2013, the patient experienced an allergic rash. The physician decided to stop therapy with SILGARD (no more doses would be administered). The outcome of allergic rash was unknown. The reporter considered allergic rash to be related to SILGARD. The physician was not sure if the event was medically significant. Additional information has been requested.

Write-up: This case was reported by the regulatory authority (GB-MHRA-EYC 00100067) and described the occurrence of fever in a 13-year-old female subject who was vaccinated with human papilloma type 16 and 18. Historic vaccination included human papilloma type 16 and 18 given on 15 October 2011 and an unspecified date. On 18 June 2012 the subject received unspecified dose of Human papilloma type 16 and 18. On 15 July 2012, 27 days after vaccination with Human papilloma type 16 and 18, the subject experienced fever, sore throat, extreme fatigue and vaginal ulceration. The subject was hospitalised. Relevant test results showed the patient was negative for glandular fever and negative for herpes simplex antibodies. Treatment included steroids, antibiotics and pain killers. At the time of reporting the events were unresolved. MHRA verbatim Text : Fever, vaginal ulcers, sore throat, extreme fatigue. To treat the symptoms 4 weeks after her last injection: steroids, antibiotics, pain killers.

Write-up: This case was received from the health authority on 22-Apr-2013. GB-MHRA-ADR 22083107. This case is not medically confirmed as it was reported by a consumer. A 13 year old female patient received an injection of human papillomavirus (manufacturer unknown, batch number, dose, route and site of administration not reported) on 18-Jun-2012. The patient already received 2 injections of human papillomavirus (manufacturer unknown) on 15-Oct-2011 and on an unknown date. On 15-Jul-2012, the patient experienced fever, vaginal ulcers, sore throat and extreme fatigue. She was hospitalised. Lab tests for glandular fever and herpes simplex antibody remained negative. To treat the symptoms 4 weeks after her last injection, the patient received corrective treatment with steroids, antibiotics and pain killers. At the time of reporting, the patient was not recovered. The MHRA considered that case serious due to hospitalisation.

Write-up: This case was received from the health authority on 24-Apr-2013. GB-MHRA-ADR 22053439. This case is medically confirmed. A 13 year-old female patient received her second dose of GARDASIL (batch and lot n. H008041, site of administration not reported) 0.5 mL intramuscularly on 16-Nov-2012. On an unknown date, the patient developed "chest pains". The chest became "very tight" later that evening at home, and eventually subsided the next day. The patient was advised to consult with her general practitioner regarding the above reaction and take advice as to whether to complete the course. The patient received first dose of GARDASIL on 09-Oct-2012 and apparently was fine afterwards. At the time of reporting, the patient recovered. The MHRA considered that case serious due to be medically significant.

Write-up: This invalid case (no patient details) was received from the health authority on 22-Apr-2013. This is a cluster of two cases concerning the same batch and event and from the same original reporter. This case is linked with E2013-02994. This case is medically confirmed. An unknown patient received an injection of GARDASIL (batch number H013055, expiry 02-2015), route and site not reported, and BOOSTRIX (batch number not reported), route and site not reported, on 09-Apr-2013. On an unreported date, post vaccination, the patient experience a severe allergic reaction. The patient outcome was not reported. Follow up information received from Merck on 24-Apr-2013: The review of lot number H013055 (bulk lot 0000129796) confirmed that this lot conformed to all quality release parameters at the time of release in July 2012, including batch documentation review, environmental monitoring data and test data were typical of the product. No atypical events occurred that might have a negative impact on product quality or safety. Additional information received from the agency on 26-Apr-2013: The patient''s initials were provided. The patient was a 13 year old female with no medical history and no reported concomitant medication. The patient received doses one and two of GARDASIL on unreported dates without any reactions. The patient received dose three of GARDASIL and dose one of BOOSTRIX (batch number AC37B069BD) IM. On 09-Apr-2013, 30 minutes post vaccination, the patient experienced a severe allergic reaction with headache, feeling hot, flushing and urticarial rash on her face and chest. No facial puffiness or itchiness was noted. The patient''s BP was 133/99 and pulse was 110bpm. After approximately 10 minutes the patient complained of difficulty swallowing. Her BP was 141/99 and pulse rate 108bpm at this stage. The patient was given 10mg IM chlorphenamine but failed to respond. The patient was alert throughout. The patient was then transferred to hospital and admitted overnight for observation and given further antihistamines and prednisolone and made a full recovery on an unreported date.

Write-up: This case was reported by a physician via a regulatory authority (IE Foreign Medicines Board # 2013-016877) and described the occurrence of allergic reaction in a 13-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), GARDASIL. On 9 April 2013 the subject received unspecified dose of BOOSTRIX (unknown route, unknown injection site), unspecified dose of GARDASIL (unknown route, unknown injections site). Less than one month after vaccination with BOOSTRIX and GARDASIL, the subject experienced allergic reaction. At the time of reporting the outcome of the event was unspecified. Follow up information received on 26 April 2013: This case was upgraded to serious. The subject had no medical history and no concomitant medication. The subject had no reaction to previous vaccinations. On 8 April 2013 the subject received 1st dose of BOOSTRIX (intramuscular, unknown injection site), 3rd dose of GARDASIL (unknown route). On 9 April 2103, 30 minutes after vaccination with BOOSTRIX and GARDASIL, the subject experienced allergic reaction, headache, feeling hot, flushing, urticarial rash on face and chest. No facial puffiness or pruritus was noted. Her blood pressure was 133/99 and her pulse was 110 bpm. After 10 minutes, she complained of swallowing difficulty. Her blood pressure was 141/99 and her pulse was 108 bpm. The subject was treated with Chlorphenamine i.m without response. The subject was hospitalized overnight for observation. The subject was treated with antihistamine and prednisolone. On 10 April 2013, the events were resolved, the subject was discharged.

Write-up: Case was received from the Health Authorities on 22-Apr-2013 (reference no. PEI2013021619). Case is medically confirmed. A 13-year-old female patient with a medical history of dizziness and sleep disorder, received a third dose of GARDASIL (lot no H01944) at about 3 p.m. on 22-Mar-2013. On the same day 8 hours later at 11 p.m., the patient developed syncope and somnolence lasting for 2 minutes, and circulatory failure lasting for 20 hours. The emergency medical service was called, but the patient was not hospitalized. At the time of reporting the patient had recovered. D1 of GARDASIL on 21-Aug-2012 and D2 of GARDASIL on 24-Oct-2012 were well tolerated.

Write-up: This case was received from health authority on 26-Apr-2013. GB-MHRA-ADR 22088057. This case is medically confirmed as it was reported by a physician. A 13 year old female patient received her 3rd injection of GARDASIL (batch and lot n. H011989, site of administration not reported) intramuscularly on 16-Apr-2013 and 16 hours later, on 17-Apr-2013, the patient presented an erythema multiforme type skin reaction. The rash was still evolving and there was no involvement of mucosal membranes so far but ticked as serious in view of potential severity of them. The patient was vaccinated with first and second dose of GARDASIL and didn''t experience any adverse events. At the time of reporting, the patient was not recovered. The foreign agency considered that case serious due to be medically significant.

Write-up: This case was received from the health authority on 30-Apr-2013. Agency Ref 2013-16907. This case is medically confirmed as it was reported by a physician. A 13 year old female patient, with no medical history, received on 11-Apr-2013 an injection of GARDASIL (batch n. H013137, site of administration not reported) 0.5 mL intramuscularly and an injection of BOOSTRIX (batch n. AC37B085AB, site of administration not reported) 0.5 mL intramuscularly and on the same day, after an unspecified time post vaccinations, the patient experienced a wheal like reaction and significant itch which was reported to have lasted for "hours". The patient received corrective treatment with antihistamines. At the time of reporting, the outcome of the patient''s reaction was unknown. The agency considered that case serious due to be medically significant.

Write-up: This case was reported by a physician via a regulatory authority (# 2013-01755) and described the occurrence of syncope in a 13-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), NEISVAC-C. On 2 April 2013, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown site of injection), unspecified dose of NEISVAC-C (.5 ml, intramuscular, unknown site of injection and batch number). On 2 April 2013, less than one day after vaccination with BOOSTRIX and NEISVAC-C, the subject experienced an hypotonus reaction as well as a short loss of consciousness with a pulse rate of 55 bpm and a blood pressure dropping down to 95/63 mmHg. Later on the blood pressure was 164/66 mmHg with a pulse of 80 bpm. These events were considered to be a syncope. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with Glucose and unspecified liquid. The events were resolved without damage within one hour. The regulatory authority reported that the events were possibly related to vaccination with BOOSTRIX and NEISVAC-C. A non-medicamentous cause could not be identified.

Write-up: Case was received from a health care professional in a foreign country on 30-Apr-2013. Case is medically confirmed. A 14-year-old female patient the second dose of GARDASIL (lot-no. H007252, route, administration site not reported) in Jul-2012. In Dec-2012, the patient developed abdominal pain. She did not eat and experienced a weight loss of about 10 kg. Hereupon she was hospitalised in Dec-2012 and was diagnosed with an eating disorder. She was stabilized and discharged with psychotherapy. On 25-Apr-2013, the patient was vaccinated with the third dose of GARDASIL. The patient again developed abdominal pain of which she could not eat her daily food ration. Examination did not reveal any pathological findings. A rehab was planned. Pain was ongoing. D1 of GARDASIL (lot no. G016831) was given in Apr-2012 and well tolerated. According to the reporter the reaction was not related to the vaccination.

Preexisting Conditions: Premature birth; Tonsillitis; No significant past medical history fit and healthy child. No other medications were being taken at the time of the vaccine. The mother has a neurological disorder similar to multiple sclerosis.

Write-up: This case was reported by a regulatory authority (Regulatory Agency # GB-MHRA-ADR 22094302) and described the occurrence of blackout in a 13-year-old female subject who was vaccinated with CERVARIX. The subject''s medical history included premature birth and tonsillitis. In 2009 the subject received unspecified dose of CERVARIX. After the first injection the subject experienced a decrease in energy, a sore throat and a high temperature. This did not resolve before the second injection was given approximately 3-4 months later. After the second injection (approximately 3-4 months after the first), the subject experienced high temperature, sore throat, boiling hot, and a continuing decline in her condition. She took paracetamol as treatment. Over the past 4 years seen paediatricians, immunologist and more recently a cardiologist due to heart blocks. The subject has had very low platelet counts, low white blood cell count and there is a potential for a blood transfusion. The subject has additionally experienced black outs (more recently in last few months), decreased weight, unable to put on weight no matter what she eats, her hair fell out but this has grown back although is now fine and blonde when her hair used to be thick and dark in colour, her nails are blue and her toes are black. She has experienced stunted growth since the injection and has not grown like her twin sister. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved with the following sequelae. Verbatim Text: Mother had cervical cancer before the age of 21, so based on history, school nurse recommended her daughter have the vaccine. The reporter (mother) stated she was apprehensive for her daughter to have the vaccine as she wasn''t familiar with possible side effects. The patient has a twin sister who also had the vaccine at the same time and has not experienced any adverse reactions. The mother mentioned she was not made aware of the side effects and given a pamphlet until after the administration. After the first injection her daughter experienced a decrease in energy, a sore throat and a high temperature. This did not resolve before the second injection was given approximately 3-4 months later. After the second injection (approximately 3-4 months after the first), her daughter experienced high temperature, sore throat, boiling hot, and a continuing decline in her condition. She took paracetamol as treatment. Over the past 4 years seen paediatricians, immunologist and more recently a cardiologist due to heart blocks. The patient has had very low platelet counts, low white blood cell count and there is a potential for a blood transfusion. The patient has additionally experienced black outs (more recently in last few months), decreased weight, unable to put on weight no matter what she eats, her hair fell out but this has grown back although is now fine and blonde when her hair used to be thick and dark in colour, her nails are blue and her toes are black. She has experienced stunted growth since the injection and has not grown like her twin sister. She had a black out approximately 8 weeks ago.

Write-up: This case was reported by a consumer via the regulatory authority and described the occurrence of myalgia in a 13-year-old female subject who was vaccinated with HPV vaccine. Historic vaccination included HPV vaccine given on an unspecified date. On 22 April 2013 the subject received an unspecified dose of HPV vaccine. On 23 April 2013, at an unspecified time after vaccination with HPV vaccine, the subject experienced myalgia, flushing, nausea and dizziness. The reporter considered that the events were clinically significant (or requiring intervention). On 25 April 2013, the events were resolved. Verbatim Text: Myalgia, flushes, nausea and dizziness.

Write-up: This case was reported by a physician via the regulatory authority (# GM-MHRA-ADR 22098176) and described the occurrence of photosensitive dermatitis in a 13-year-old female subject who was vaccinated with HPV vaccine (unknown manufacturer). Historic vaccination included human papilloma type 16 + 18 vaccine given on an unspecified date. On 18 April 2013 the subject received the second dose of HPV vaccine (route unknown, batch number unknown). On 21 April 2013, 3 days after vaccination with HPV vaccine, the subject experienced photosensitive dermatitis; developed urticarial rash to exposed skin after brief exposure to the sun (approximately 10 minutes). The subject was hospitalised. At the time of reporting the events were unresolved. Third human papilloma virus vaccine. Transient rash locally after second vaccine. Developed urticarial rash to exposed skin after brief exposure to sun, approximately 10 minutes. Photosensitive dermatitis. Required accident and emergency attendance.

Write-up: This case was received from the health authority on 07-May-2013. GB-MHRA-ADR 22097491. This case is not medically confirmed as it was reported by a consumer. A 13 year old female patient, who already received an injection of HPV vaccine(manufacturer unknown) in the past, received another injection of HPV vaccine (manufacturer unknown, batch number, dose, route and site of administration not reported) on 22-Apr-2013. On 23-Apr-2013, the patient experienced myalgia, flushes, nausea and dizziness. The patient fully recovered on 25-Apr-2013. The agency considered that case serious due to be medically significant.

Write-up: This case is medically confirmed as it was reported by a physician. A 13 year old female patient (weight: 70 kg) received third dose of human papillomavirus vaccine (manufacturer unknown, batch number, dose, route and site of administration not reported) on 18-APR-2013 and on 21-APR-2013 developed urticarial rash on photosensitive dermatitis to exposed skin after brief exposure to sun, approximately 10 minutes. The patient went to accident and emergency attendance. The patient already experienced transient rash locally after second dose of human papillomavirus vaccine (manufacturer unknown). At the time of reporting, the patient was not recovered. The agency considered that cause serious due to hospitilisation and due to be medically significant.

Write-up: Information was obtained on a request by the Company from the agency concerning a 13 year old male patient. On 08-MAR-2013 the patient was vaccinated with the first dose of GARDASIL (Batch # H020012) (1 dose unspecified, 1 time, intramuscular route) and the first dose of VARILRIX (Batch # A70CC272A) (1 dose unspecified), 1 time, subcutaneous route). Concomitant therapy was not reported. On 08-MAR-2013, immediately after vaccination the student fainted. LOC<10s. Once positioned supine with legs elevated he immediately regained consciousness. The patient recovered on 08-MAR-2013. The agency considered the syncope to be possibly related to GARDASIL and VARILRIX. The original reporting source was not provided. Follow up information received which reported that batch number H020012 has been verified with a valid lot number 0613AE for GARDASIL. Additional information is not expected. 20MAY2013. This is an amended report. Upon internal review the loss of consciousness was considered a medically significant event.

Write-up: This case was reported by the regulatory authority (# GB-MHRA-EYC 00100630) and described the occurrence of fever in a 13-year-old female subject who was vaccinated with human pilloma type 16 + 18 vaccine. On 3 May 2013 the subject received an unspecified dose of Human papilloma type 16 + 18 vaccine (1 IU Axa). On 3 May 2013, 9 hours after vaccination with Human papilloma type 16 + 18 vaccine, the subject experienced fever (up to 38.5). On 3 May 2013, several hours after vaccination the subject experienced vomiting and the same day the subject experienced dizziness and butterflies in stomach (abnormal physical sensation). The subject was still pyrexial 12 hours after onset. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. Fever (up to 38.5) butterflies in stomach, vomited, dizzy. Fever up to 38.5 started 9 hours following injection. Also complained of butterflies in stomach, was sick several hours after symptoms started. Still pyrexial 12 hours after onset.

Write-up: This case was received from the health authority on 16-May-2013. REF 2013-017091. This case is medically confirmed. The primary reporter is a physician. A 13-year-old female patient, with no reported medical history or concomitant medication, was vaccinated on 08-Apr-2013 with a child dose of GARDASIL (batch and lot no. H013137, Exp. Date: 31-MAR-2015, site of administration not reported) 0.5 mL intramuscularly and a few hours post vaccination, on 08-Apr-2013, she developed abdominal pain, back pain, anorexia and a low grade temperature. The patient was reviewed by her GP, doctor on call and seen in A&E. All investigations were negative. The reactions lasted 10 days and the patient fully recovered on an unreported date. This case was considered to be serious by agency as an other medically important condition.

Write-up: This case was received from the health authority on 16-May-2013. GB-MHRA-ADR 22105305. This case is not medically confirmed as it was reported by a consumer. A 13 year old female patient (weight: 34.02 kg), with no medical history reported, received an injection of human papilloma virus (manufacturer unknown, batch number, dose, route and site of administration not reported) on 03-May-2013 and on the dame day, 9 hours post vaccination, the patient presented fever up to 38.5. On the same day, she also experienced butterflies in stomach, vomited and was dizzy and sick several hours after symptoms started. She still had pyrexia 12 hours after onset. At the time of reporting, the patient was recovering. The agency considered that case serious due to be medically significant.

Write-up: This case was reported by a physician and described the occurrence of convulsion in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 30 July 2011, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site). From August 2011, less than one month after vaccination with CERVARIX, the subject experienced convulsion, grip strength decreased and weakness on the left hand. Since then, the events occurred once or twice daily, irrespectively of the time. The events were considered as clinically significant by the reporter. On 10 September 2011, the subject was vaccinated with 2nd dose of CERVARIX. On 31 March 2012, the subject was vaccinated with 3rd dose of CERVARIX. On an unspecified date, the subject underwent an electroencephalogram and a head computerised tomography for which no abnormalities were observed. In May 2013, the subject was still having those symptoms and was then treated with SOLANAX. At the time of reporting the events were unresolved. Although it was reported that the subject''s daily live was not really impacted by the events, the serious criteria was changed by the reporter into disabling on the FU from 20 May 2013. Clarification has been requested.

Write-up: This case was reported by the regulatory authority (# GB-MHRA-EYC 00100712) and described the occurrence of tiredness in a 13-year-old female subject who was vaccinated with HPV vaccine (Unknown manufacturer). Concurrent medications included PIZOTIFEN and MIGRALEVE. On an unspecified date the subject received unspecified dose of HPV vaccine. On 5 May 2013, at an unspecified time after vaccination with HPV vaccine, the subject experienced tiredness, sickness, dizziness and headache. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. Verbatim Text: Sickness, tiredness, dizzy and headaches. Severe side affects.

Write-up: This case was received from the health authority on 15-May-2013. GB-MHRA-ADR 22105300. This case is medically confirmed as it was reported by a physician. A 13 year old female patient (weight: 26 kg) received an injection of human papillomavirus vaccine (manufacturer unknown, batch number, dose, route and site of administration not reported) one month before reporting to HA and was concomitantly treated with flucloxacillin from 26-Apr-2013. On 05-Apr-2013, the patient developed hair thinning at the crown of the head. The patient''s medical history included acute non-suppurative otitis media, acute tonsillitis, asthma, enuresis, gastrointestinal symptoms, herpes zoster, immunisation, infectious disease prophylaxis, molluscum contagiosum, skin disorder and unspecified viral warts. The patient had family history of blood disorder. At the time of reporting, the patient was not recovered. The agency considered that case serious due to be medically significant.

Write-up: This case was received from the health authority on 23-May-2013. GB-MHRA-ADR 22113158. This case is not medically confirmed as it was reported by a consumer. A 13-year-old female patient, with no reported medical history or concomitant medication, received an injection of GARDASIL (batch no. unknown; dose, route and site of administration not reported) on 19-Apr-2013 and, 4 hours later, on 19-Apr-2013, she started to experience headache. On the same day she also experienced extreme aching in limbs, feeling sick (lasting overnight) then extreme exhaustion, dizziness and weak to the point of not being able to stand up. She felt like this for three more days with extreme nausea. She was eventually able to return to school five days later. She spoke to school healthcare. The patient fully recovered on 23-Apr-2013. The agency reported that all the reactions started on 19-Apr-2013 (date of vaccination) but the latency was reported as one day for all the reactions except from headache (4 hours). The patient had already received an injection of GARDASIL on an unreported date, but it was not reported whether she had adverse events or not. The agency considered this case to be serious as an other medically important condition.

Write-up: This case was received from the health authority on 23-May-2013. GB-MHRA-ADR 221 12063. This case is not medically confirmed as it was reported by a consumer. A 13 year old female patient (weight: 34.92 kg), with no medical history reported, received an injection of GARDASIL (batch number, dose, route and site of administration not reported) on 09-May-2013 and was concomitantly treated with hydrocortisone. On 09-May-2013, fever and moderate heat and site swelling and itching were present 5 hours later. Viral rash appeared on skin on trunk by 8 hours after injection and disappeared by 24 hours from injection. She also experienced tiredness on the same day which was bad enough to cause 1 day missed school and she was also tired the next day but it was a weekend day. 48 hours after, injection site was still swollen slightly and was still hot. Eczema flare up in same arm on an unknown date and was still present. The patient received corrective treatment with analgesic for fever. At the time of reporting the patient was not recovered from eczema aggravated, feeling hot, fever, injection site itching, injection site swelling and tiredness. The patient recovered from skin rash. The MHRA considered that case serious due to be medically confirmed.

Write-up: This case was reported by a pharmacist and described the occurrence of epileptic seizure in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included epilepsy. Concurrent medical conditions included cerebral palsy. In April 2012, the subject received 3rd dose of CERVARIX (intramuscular, administration site unknown, batch number not provided). In April 2012, 3 weeks after vaccination with CERVARIX, the subject experienced epileptic seizure. The subject was treated with antiepileptic drug and it resolved. On an unspecified date, she began to have mild seizures which resolved with antiepileptic therapy. From June 2012, 2 months after vaccination with CERVARIX, the subject experienced myalgia. Tests revealed no causative factor. Pain resolved owing to treatment with muscle relaxant around the Spring 2012, When the dose was decreased, pain recurred and the subject cried and complained of pain at night. In July 2012, the subject experienced wrist pain and hand weakness (inability to hold a pencil) followed by knee pain. After muscle relaxant, the symptoms improved. In March 2013, pain was generalized. In May 2013, the subject experienced severe headache and generalized pain. The subject was treated with VOLTAREN but the drug showed insufficient effect. In addition, the subject had regular menstruation until the fall of 2012, Afterward, she had menstruation only once every 2 to 3 months. The pharmacist considered the events were clinically significant (or requiring intervention). The subject was placed under observation on an unspecified date. In April 2012, epileptic seizure was resolved. In September 2012, wrist pain, knee pain and hand weakness were improved. At the time of reporting, generalized pain, headache, irregular menstruation and myalgia were unresolved. Seizure was resolved. The outcome of crying was unspecified.

Write-up: This case was reported by a physician via a sales representative and described the occurrence of syncope in a 13-year-old male subject who was vaccinated with HAVRIX junior (GlaxoSmithKline). On 4 May 2013, the subject received unspecified dose of HAVRIX junior (intramuscular, unknown injection site). On 4 May 2013, less than one day after vaccination with HAVRIX junior, the subject experienced syncope and tachycardia which required assistance at the emergency service. The physician considered the events were clinically significant (or requiring intervention). On 4 May 2013, the events were resolved.

Write-up: This case was reported by the regulatory authority (GB-MHRA-ADR 22114757) and described the occurrence of alopecia totalis in a 13-year-old female patient subject who was vaccinated with CERVARIX. The subject''s medical history included psoriasis. On an unspecified date the subject received unspecified dose of CERVARIX (intramuscular). In February 2010, approximately 7-10 days after vaccination with CERVARIX, the subject experienced alopecia totalis. The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the event was improved. MHRA Verbatim Text : Alopecia totalis (total hair loss from scalp). The patient and patient''s mother believe it is a result of the CERVARIX vaccination. Reaction 7-10 days. Medically significant details: affected the patient psychologically.

Write-up: This case was reported by a physician via a sales representative and described the occurrence of dizziness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 30 April 2013, the subject received 3rd dose of CERVARIX (administration site and route unknown). On 30 April 2013, less than one day after vaccination with CERVARIX, the subject experienced dizziness and numbness of right ankle. The subject was hospitalised for 2 days from 30 April to 01 May 2013. On 1 May 2013, the events were resolved.

Write-up: Initial information has been received from a physician concerning a 13 years old girl patient with no primary disease/concurrent conditions or anamnesis, who on 04-OCT-2012 was vaccinated with the first injection of GARDASIL injection syringe, 0.5ml once a day intramuscularly for prophylaxis of HPV infection (Lot No: 9QN05R). On 04-OCT-2012, the patient received the first inoculation (Lot No: 9QN05R). On 21-DEC-2012, the patient received the second inoculation (Lot No: 9QN05R). On 30-APR-2013, the patient received the third inoculation (Lot No: 9QN07R). No information on concomitant medication was provided. On 10-MAY-2013, weakness of limbs attacks appeared rapidly from morning and distal limb muscle significantly weakness appeared. Tendon reflex testing was normal. About blood drawing, CK and aldolase did not increased. Head MRI showed no abnormality. About cerebrospinal fluid tests, albumincytological showed no dissociation. About NCV tests, tibial showed minimum of the normal range. And the patient was hospitalized. On 23-MAY-2013, the patient was discharged from the hospital. Rehabilitation training trial was underway. And she could shuffle her feet along. At the time of the report, the patient had not recovered from weakness of limbs attacks or muscular weakness. The reporter''s comment: It might be Guillain-Barre syndrome or somatoform disorder. The reporting physician considered that weakness of limbs attacks and muscular weakness were definitely related to GARDASIL. The reporting physician considered weakness of limbs attacks and muscular weakness to be serious due to hospitalization. Upon internal review, Guillain-Barre syndrome was determined to be other important medical event. Additional information has been requested.

Write-up: This spontaneous report as received from a health care professional refers to a 13 year old female patient. On 23-MAY-2013, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb (manufacturer unknown)(Lot number, expiry date and dose were not reported), intramuscularly. On 23-MAY-2013, the patient experienced syncope vasovagal. Approximately on an unknown date in May 2013, the event syncope vasovagal was recovered/resolved. The reporter considered syncope vasovagal to be related to quadrivalent Human papillomavirus (Types 6, 11, 16, 18) Recomb (manufacturer unknown). On 28-MAY-2013 follow up information was received. Initial information has been received from a physician via PMDA concerning a 13 year old female child who had an (adverse drug reaction)ADR history of urticaria following influenza vaccination at the age of 11 years old, and egg allergy was found by the examination at that time. On 23-MAY-2013, the patient was intramuscularly vaccinated with the first injection of GARDASIL (batch/lot # was reported as 9QN08R) (injection site not reported). No information on concomitant medications has been provided. On 23-MAY-2013, when she was sitting on the sofa after injection of GARDASIL at 16:25, suddenly she recurved her body with 10 seconds convulsion and was in a stupor of anemic condition. At 16:35, (blood pressure)BP was 126/74mmHgm and pulse was 54. Anemic condition decreased, and she came to herself. At 16:55, BP was 114/72mmHg, pulse was 72, and SpO2 was 99%. At 18:30, there was nothing special. She had recovered on the same day. On 24-MAY-2013, she had feeling of lassitude but attended school as usual. The reporting physician did not assess the causal relationship of syncope vasovagal and convulsion. The reporting physician considered that syncope vasovagal was non-serious, but did not assess the seriousness of convulsion. Upon internal review, convulsion was determined to be serious as an other important medical event. No further information is available.

Write-up: This case was received from the health authority on 27-May-2013. GB-MHRA-ADR 22116412. This case is medically confirmed as it was reported by a health care professional. A 13 year old female patient, with no medical history reported, received an injection of GARDASIL (batch number H019054, site of administration not reported) 0.5 mL intramuscularly on 14-May-2013 and experienced immediate faint following injection and was very slow to recover. The patient also complained of headache and was reluctant to open eyes, was slow to respond to questioning. It was a very unusual faint and paramedics were called and the patient was transferred to hospital. The onset dates for the adverse events were not reported by the MHRA but we suspected that all the events occurred on the same day of vaccine administration. At the time of reporting, the patient was not recovered. The MHRA considered that case serious due to be medically significant.

Write-up: Serious case received from a healthcare professional (doctor) via the regulatory authority on 03-Jun-2013. Medically confirmed. A 13-year-old female patient had received the third dose of GARDASIL (batch number not reported) on 14-May-2013. The vaccine was administered at school following to the vaccination program. A few seconds later, the patient experienced a vagal reaction. The standard procedure (lay down the patient, feet up, surveillance of the vital parameters) was observed. After 10 minutes, the patient could sit up again, but 10 minutes later, she had another vagal reaction and sunk deeper away. Vaccinating doctor kept her conscious by talking to her. Her blood pressure remained low but normal (90/60), her pulse slowed down but did not fade away. As it was not possible to move her from one position to another without having another vagal reaction, the ambulance was called and she was hospitalised. During her stay at the hospital, she experienced the same deep vasovagal reaction several times, with urine loss, when trying to move her in her bed. This lasted for 2 days. Several examinations were performed (neurological and tilt test included), they did not show any anomalies. Patient was discharged on 16-May-2013, but on 17-May-2013, she experienced other vagal attacks and was hospitalised again until 23-May-2013. Attacks lessened and the hospital physicians'' hypothesis was: underweight with a possible psychological component and a slight inflammation of the stomach. Patient returned to school in the same week, for a while, but had to return back home because of abdominal pain, she could not stand up straight. Hospital physicians thought there was no link with the vaccination, but did not communicate this information to the parents. The vaccinating doctor reported that the patient has not been functional for 3 weeks following to the vaccination. Outcome for the vagal reaction, urine loss, slow pulse, low blood pressure, abdominal pain, stomach inflammation and suspicion of psychological component were not reported, but the reporter mentioned that the patient had not been functional following to the vaccination, without further details.

Write-up: This is a spontaneous report from a contactable nurse received via a company representative. A 13-years-old female patient received PREVENAR 13 0.5ml single dose via intramuscular route on 16May2013. Folic acid and ZINCOVIT tablets were reported as Interacting Products. Medical history included sickle cell anemia from 22Dec199 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced unable to raise up left arm (monoplegia) assessed as serious by reporter on 16May2013.

Write-up: This case was reported by a physician and described the occurrence of vertigo in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included cerebral concussion (April 2011). Concurrent medical conditions included headache since the cerebral concussion. Concurrent vaccination included 1st dose of CERVARIX (GlaxoSmithKline) given in April 2012. In June 2012, the subject received 2nd dose of CERVARIX (intramuscular, unknown deltoid). In 2012, between June and October, less than one year after vaccination with CERVARIX, the subject experienced vertigo. The subject was hospitalised due to the vertigo. In October 2012, 4 months after vaccination with CERVARIX, the subject experienced numbness. In 2012, less than one year after vaccination with CERVARIX, the subject appeared to have walking difficulty. At the time of reporting, the numbness was unresolved and the other events were unspecified. The subject received the 3rd dose of CERVARIX in December 2012 (unknown route and unknown deltoid). According to the physician, the numbness was related to the cerebral concussion.

Write-up: This case was received from a physician in a foreign country on 06-Jun-2013 with additional information received on 07-Jun-2013. This case is medically confirmed. A 13 year old patient of unknown gender received dose three of GARDASIL (batch number not reported), route and site not reported, on 13-Mar-2013. On an unreported date, one day post vaccination, the patient experienced a seizure which is being investigated. The patient outcome was not reported. The reporter stated that the event had been reported to the IMB. Upon internal review the event was considered to be medically significant.

Write-up: This case was received from the health authority on 06-Jun-2013. REF 2013-017285. This case is medically confirmed as it was reported by a physician. A 13 year old female patient received her third dose of GARDASIL (batch number H013137, site of administration not reported) (Expiration date: 31-MAR-2015) 0.5 mL intramuscularly on 17-May-2013. The patient was reported to be well for 10 minutes post vaccine but became tonic after this and arched her back for approximately 10 seconds followed by tonic clonic movements of her limbs for a further 10 seconds with loss of consciousness. There was no tongue biting or no incontinence. The reporter indicated that the patient''s recovery was very protected with headache and fatigue and the patient was very weak and unable to sit without feeling faint for several hours. The reporter indicated that the patient was hospitalised, laid supine and observed for 30 hours and is due to have an EEG and further evaluation. "Epileptic seizure" was coded as an adverse event by regulatory authority. The patient experienced a previous syncope with tonic clonic movements post first dose of GARDASIL. At the time of reporting, the patient had made a complete recovery. The regulatory authority considered that case serious due to hospitalization.

Write-up: This case was reported by a consumer and described the occurrence of uterine hemorrhage in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional had not verified this report. On 7 June 2013, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site, batch number not provided). On 7 June 2013, in the evening, within hours of vaccination with CERVARIX, the subject experienced uterine hemorrhage. The reporter considered the event was clinically significant (or requiring intervention). At the time of reporting, the outcome of the event was unspecified. No further information was expected. Case was closed.

Write-up: Information has been received from a physician concerning a 13 year old female patient who had a history of epilepsy on 25-FEB-2013 was intramuscularly vaccinated with GARDASIL (Lot No.: 9QN07R), 0.5mg once a day. Suspect therapy included ONON (oral, strength, totally daily dose and start date not reported) for the treatment of pollinosis (duration and dose were not reported). Other concomitant medications were not provided. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL (lot # not reported) (strength and total daily dose not reported). On an unspecified date, the patient was vaccinated with the second dose of GARDASIL (lot # not reported) (strength and total daily dose not reported). On 25-FEB-2013, the patient was vaccinated with the third dose of GARDASIL. In the morning of 13-MAR-2013, she lost of consciousness due to epileptic seizure and admitted to other hospital. Epilepsy didn''t occurr until that time. Epilepsy also occurred on 08-APR-2013, 23-APR-2013, 27-MAY-2013 and 31-MAY-2013. At the time of the report, action taken with regard to pranlukast hydrate was unknown and the outcome of epileptic seizure was unknown. The physician''s comment: the patient didn''t visit the hospital after 25-FEB-2013, the relationship with GARDASIL was unknown. The reporting physician felt that the relationship between epileptic seizure and GARDASIL was unknown. Pranlukast hydrate was suspect drug. The reporting physician considered that the epileptic seizure was serious due to other important event. Additional information is not expected.

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail report (reference number 319793), concerning a 13 year old female patient. The patient''s medical history was not reported. On 15-MAY-2013 the patient was vaccinated with GARDASIL, administered once, intramuscularly at a dose of 0.5 ml (Batch number G018445) and with HEPATITIS B VACCINE (manufacturer unknown), administered once, intramuscularly at a dose of 1 ml (Batch number 018409, lot number 1682AA). No other co-suspected medications and no concomitant medications were reported. On 15-MAY-2013, within 10 minutes of vaccination, the patient developed headache, felt dizzy and then 10 minutes later legs went numb and weak. Furthermore, the following was stated: assessed at emergency dept for 2 hours then discharged was walking independently when discharge no diagnosis. The outcome of headache, muscular weakness and dizziness was reported as unknown. Furthermore the three events were reported as serious with the serious criterion caused or prolonged inpatient hospitalisation. The reporter considered the adverse events to be possibly related to HEPATITIS B VACCINE (manufacturer unknown) and GARDASIL. The original reporting source was not provided. Additional information is not expected.

Write-up: This case was reported by a physician and described the occurrence of swollen wrist in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In September 2012 the subject received 1st dose of CERVARIX (intramuscular, unknown injection site). Lot number not provided. In October 2012, 1 month after vaccination with CERVARIX, the subject experienced swollen wrist. In November 2012 the subject received 2nd dose of CERVARIX. In January 2013, 4 months after vaccination with 1st dose of CERVARIX, the subject experienced hyperthermia for 5 days, foot pain, abdominal pain, malaise, swollen lymph node, buccal erythema and orthostatic dysregulation. The subject was hospitalised. No information about hospitalisation was provided. At the time of reporting, the events were improved but malaise remained unresolved. The physician considered the events were related to vaccination with CERVARIX.

Write-up: This case was reported by a healthcare professional via a regulatory authority (V13000310) and described the occurrence of Guillain Barre Syndrome in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 1 April 2013 the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). On 25 April 2013, 24 days after vaccination with CERVARIX, the subject experienced Guillain Barre syndrome, left hand tremor and grip strength decreased. The regulatory authority reported that the events were clinically significant (or requiring intervention). A nuclear magnetic resonance of brain was done and showed no abnormality. At the time of reporting, the symptoms tended to improve but still remained. Since the events occurred 3 weeks after the vaccination, the possibility that the subject had Guillain-Barre syndrome could not be ruled out considering the symptoms.

Write-up: This case was reported by a pharmacist and described the occurrence of facial palsy in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In January 2013 the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). Lot number not provided. On 17 June 2013, 5 months after vaccination with CERVARIX, the subject experienced facial palsy. The pharmacist considered the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved.

Write-up: This misuse case was received from a health care professional on 05-Jun-2013. PIVOTAL 17062. This case was medically confirmed. A female patient received her second dose of GARDASIL (batch and lot number H008041) route and site of administration not reported, 3 weeks after the first injection of GARDASIL which is an inappropriate schedule of administration. No adverse effect at the time of administration was reported. Follow up received from the initial reporter on 19-Jun-2013: This case has been upgraded to serious. The patient was 13 years old and was not taking any other medication. The patient received the first dose of GARDASIL (batch number not reported), 0.5 mls, IM, on 16-Oct-2012, three weeks before the second dose. The patient received dose two of GARDASIL, 0.5 mls, IM, on 06-Nov-2012. The reporter considered the event to be serious as it was a clinically important medical event as it was an error by the school nurse team and that others may also have received vaccines on these dates. The reporter sought advice from PHE and was told not to repeat dose two but to carry on and give dose three.

Write-up: Case received from a consumer on 21-Jun-2013. Case not medically confirmed. A 13-year-old female patient experienced headache, dizziness and faint after she had received the second dose of GARDASIL (batch number not reported) on an unspecified date. The patient visited the primary care center and no anomaly was detected. After that, since the adverse event was still occurring, she visited the emergency room 3 times and she was referred to a central hospital. Some tests were performed such as CT-scan and laboratory tests, which found normal results. After hospitalisation the patient started to be limited in walking, showing imbalance and lack of strength for 4 weeks. An MRI was subsequently performed, which did not show any anomaly. The first dose of GARDASIL (batch number not reported) administered on an unspecified date had not been well tolerated since the patient started to experience headache and was treated with paracetamol. This was still ongoing at the time of the administration of the second dose. It is noteworthy that the reporter was a patient''s relative. At the time of reporting the patient had not recovered.

Write-up: This case was reported by a pharmacist and a physician and described the occurrence of fibromyalgia in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included 1st dose of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given in April 2012. History of vaccination was not provided. In June 2012, the subject received 2nd dose of CERVARIX (0.5 ml, intramuscular, unknown injection site). In June 2012, immediately after vaccination with CERVARIX, the subject experienced generalized pain. The subject visited a medical institution where she was treated for suspected juvenile rheumatoid arthritis. At the time of reporting, the subject had visited departments of nephrology, rheumatology and collagen disease at medical center. Fibromyalgia was diagnosed. The reporters considered the events were clinically significant (or requiring intervention). At the time of reporting, the outcomes of the events were unspecified.

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR319726) concerning a 13 year old male patient. On 21-MAR-2013 the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) (manufacturer unknown) (lot number 1682AA, batch number H018644) dose 1, subcutaneous in the left arm, and with varicella virus (manufacturer unknown) dose 1, intramuscular in the right arm (batch number A70CC015A). On 21-MAR-2013, the patient fainted after receiving vaccinations and was briefly unconscious for 5 secs. The patient was pale but responded good. There were no signs of respiratory distress or urticaria. The patient recovered on 21-MAR-2013. The reporting agency considered the event to be possibly related to quadrivalent human papillomavirus (types 6, 11, 16, 18) (manufacturer unknown) and varicella virus (manufacturer unknown). Upon internal review, unconscious was considered medically significant. The original reporting source was a health department. Additional information is not expected.

Write-up: This case was reported by a physician and described the occurrence of generalized pain in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included cochlea implant, mental disorder and migraine. On 27 May 2013, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site and batch number). At an unspecified date, less than one month after vaccination with CERVARIX, the subject experienced pain of lower extremities, abdominal pain and headache. The pain was generalized. The subject was hospitalised. At the time of reporting the events were unresolved.

Write-up: This case was reported by a physician and described the occurrence of weakness of limbs in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site and batch number). Three weeks after vaccination with CERVARIX, the subject experienced weakness of the right hand and foot and left hand cramping. The weakness of the right hand and foot improved slightly and the subject gradually became able to put strength into them. At the time of reporting, the events were unresolved. The cramping in the middle, the ring and the little finger still persisted. Follow-up information received by a regulatory authority (V13000310) on 26 June 2013: This case was upgraded to serious. This case was identified as a duplicate of B0902199A. Case B0902199A was voided and all the future correspondence will be added to the present case which stands as case of record for this subject. On 1 April 2013, the subject received 3rd dose of CERVARIX. On 25 April 2013, 24 days after vaccination with CERVARIX, the subject experienced shaking of the left hand and decreased grip strength of hands. Although the symptoms gradually improved, the decreased grip strength of hands and shaking of the third to fifth fingers of the left hand as if she played volleyball persisted. On 17 July 2013, the symptoms tended to improve but still remained. The physician considered the events were clinically significant (or requiring intervention). Since the events occurred 3 weeks after the vaccination, the possibility that the subject had Guillain-Barre syndrome could not be ruled out considering the symptoms. At the time of reporting, the events were unresolved.

Write-up: This case was reported by a physician via a regulatory authority (V13000351) and described the occurrence of headache in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included chronic headaches. Subject''s body temperature before the vaccination was 36 deg. C. On 27 May 2013, the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, left deltoid). On 28 May 2013, 1 day after vaccination with CERVARIX, the subject experienced headache and pain in extremity. On 29 May 2013, the subject visited a hospital for consultation. Analgesic medication was given but the symptoms didn''t improve. On 4 June 2013, the subject was referred to another hospital as headache persisted. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. The causal relationship to CERVARIX was unassessable. The events were related to chronic headaches.

Write-up: This case was received from the health authority on 24-Jun-2013. GB-MHRA-ADR 22145701. This case is not medically confirmed as it was reported by a consumer. A 13 year old female patient, with medical history of impaired hearing with regular check ups at hospital and was stable for 7 years, received in 2013 an injection of GARDASIL (batch number not reported), dose, route and site of administration not reported. In Apr-2013, the patient presented deafness of both ears. After vaccination, hearing loss dropped further and has had quite a bit big impact. The patient experienced hearing loss after injection, the hospital have the audiology graphs. At the time of reporting, the patient was not recovered. The regulatory authority considered that case serious due to be medically significant.

Write-up: Initial information has been received from a physician via Health Authority (PDA_2013/01, V13000342) concerning a thirteen year old female patient. According to medical history interview including underlying disease, allergy, past history of vaccination/disease during recent one month, concomitant medications, past history of ADR (adverse drug reaction), status of growth, the patient had no problem. The patient had no family history. The body temperature before vaccination was 36.3 C (on 07-JAN-2013). On 07-JAN-2013, she was vaccinated with the third dose of GARDASIL injection drug (intramuscularly, batch#9QN07R), (third time of vaccination)(dose, injection site or indication was not reported. No concomitant medications was reported. On an unspecified date, she was vaccinated with GARDASIL intramuscularly (IM) injection drug (batch# 9QN04R, lot# 0308AA), (first time of vaccination). On an unspecified date, she was vaccinated with GARDASIL intramuscularly (IM) injection drug (batch#9QN05R, lot# 0564AA), (second time of vaccination). On 07-JAN-2013, she was vaccinated with GARDASIL intramuscularly (IM) injection drug (batch# 9QN07R), (third time of vaccination). About five minutes later, she showed sign of shock and the face turned pale. The blood pressure was 61/31 (mmHg) and the pulse rate was 72 (/min). She lost consciousness. She was put on oxygen 6L/ min. for an hour. In one hour, she was recovered and walked to home. Reporter''s comments: none. The reporting physician felt that vasovagal reaction was related to GARDASIL. He did not assess the relationship of shock and loss of consciousness to the vaccine. Other possible causes was ruled-out. The reporting physician felt that vasovagal reaction was non-serious. He did not assess the seriousness of shock and loss of consciousness. Upon internal review, shock and loss of consciousness was determined as serious due to other important medical events. Additional information has been requested - for initial versions from banyu reports we always add this statement.

Write-up: Initial information has been received from a physician concerning a thirteen year old patient (gender unknown). In the beginning of June 2013, the patient was vaccinated with GARDASIL IM injection drug, 0.5milliliter (ml), 1 per day (time of vaccination, injection site or indication was not reported). No concomitant medications was reported. In the beginning of June 2013, after the vaccination, hypoaesthesia and tremor on the extremities developed. One month later, as of the reporting date, the symptoms persisted. The patient had not recovered from hypoaesthesia and tremor on the extremities. Tests such as electroencephalogram is scheduled. Reporter'' comment: none The reporting physician felt that hypoaesthesia and tremor on the extremities were related to GARDASIL. The reporting physician considered hypoaesthesia and tremor on the extremities as serious due to other important medical events. Additional information has been requested.

Write-up: Case received from a health care professional on 01-Jul-2013. Case medically confirmed. A 13-year-old female patient (weight 54,8 kg, height 161 cm) received the first dose of GARDASIL (lot-no. J000282) via intramuscular route on 28-May-2013 at 3 PM. PN 29-May-2013, at 10 AM, the patient developed circulatory collapse, unconsciousness and fell on her face. She was hospitalised and gingival suture was needed. At the time of reporting the ocutome was not reported. Corrective version created on 08-Jul-2013 in order to include the Health Authorities as reporter and to correct the reporters qualification in reporter screen. Case was received via Health Authorities on 01-Jul-2013 (ref. number PEI2013037039).

Write-up: This case was reported by a physician and described the occurrence of myalgia of lower extremities in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX (GlaxoSmithKline) 1st and 2nd dose given on 13 September 2011 and 11 October 2011. On 19 March 2012 the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, unknown injection site). In March 2012, less than one month after vaccination with CERVARIX, the subject experienced myalgia of lower extremities and numbness. The subject visited several orthopedic departments but the cause of symptoms was not found. The subject also experienced ligament injury in the hip joint and leg and hernia. The physician considered the events were disabling. The subject was treated with LOXONIN with no improvement. At the time of reporting, myalgia and numbness were unresolved, the outcome of the other events was unspecified.

Write-up: Case received from Health Care Professional (physician) on 01-JUL-2013 through health authority (additional information received by e-mail on 03-JUL-13). Case medically confirmed. A 13 year old female patient was vaccinated on 28-JUN-2013 with the third dose of GARDASIL (batch n. not reported). On the same day, 3 hours post-vaccination, she presented with a scarlet fever-like rash on the face and neck, nuchal rigidity, trismus and headache. She went to the ER twice, were antihistamines were prescribed. At the time of reporting she had not yet recovered; she was complaining of marked asthenia and the rash was desquamating. The case is closed.

Write-up: This case was reported by a pediatrician, via a GSK sales representative, and described the occurrence of syncope in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Initial information received via sales representative on 12 June 2013 and follow-up received directly from pediatrician on 14 June 2013 were processed together. This case was linked to case B0899132A (same family twin sister, same reporter). Patient''s medical conditions included previous vasovagal malaise related to severe pain. On 03 January 2013, the subject received a 1st dose of CERVARIX (batch, route and injection site unknown). About 10 minutes after vaccination the subject had a syncope which lasted 2-3 seconds. On 10 June 2013, more than 1 month after the first dose (drug dose administration interval too long), the subject received a 2nd dose of CERVARIX (batch, route and injection site unknown). About 10 minutes later, while the subject was lying down, she had a syncope. At the time of reporting, the effects were resolved. The pediatrician considered the effects were probably related to vaccination with CERVARIX. Upon follow-up received on 04 July 2013: This case was upgraded to serious as it was considered by the pediatrician as clinically significant, intervention required. The subject weighed 51 kg and measured 161 cm. On 03 January 2013, the first dose of CERVARIX (batch AHPVA135CB) was administered intramuscularly in left deltoid. About 5 minutes later, with very short prodromes (a few seconds), the subject had a severe malaise with loss of consciousness for 2-3 seconds and fall corresponding to a clinical presentation of vagal malaise. The subject recovered totally and immediately. The subject was put in lay down position with legs raised. The second dose of CERVARIX (batch AHPVA135CB) was administered intramuscularly in left deltoid on 10 June 2013. The same reactions occurred with a brief loss of consciousness which resolved in a few seconds. At the time of reporting, all effects were resolved. The pediatrician considered the events as also possibly related to subject''s medical history of vagal malaise.

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR321041) concerning a 13 years old female patient. On 05-JUN-2013 the patient was vaccinated with the second dose of GARDASIL (batch number H019846, lot number 0613AE, exp. date 02-APR-2015) (1 dose unspecified, 1 time), intramuscular injection (given second) and the first dose of varicella virus vaccine live (manufacturer unknown) (lot number reported as A70CC318A) (1 dose unspecified, 1 time), subcutaneous (given first). Concomitant medications were not reported. On 05-JUN-2013, patient experienced loss of consciousness immediately post GARDASIL immunisation. Twitchy and jerky movements as regained consciousness. Pale and cyanotic lay in recovery position. Recovered quickly able to sit up after 15 minutes and have a drink. The relationship between GARDASIL and varicella virus vaccine live (manufacturer unknown), and the event was reported as possible. The original reporting source was the State/Territory Health Department. Upon internal review, loss of consciousness was considered to be medically significant. Additional information is not expected.

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR321453) concerning a 13 year old female patient. On 05-JUN-2013 the patient was vaccinated with a dose of GARDASIL lot # 0272AE, batch#H011498, expiring 02-MAR-2015, 0.5 ml, intramuscular. On 05-JUN-2013, the patient experienced difficulty breathing, feeling of upper airway and constriction. The outcome of the events was reported as unknown. It was administered adrenaline to the patient, as a treatment for the AE, and paramedics transferred her to emergency department. The agency considered the events to be life threatening. The agency considered the events to be possibly related to GARDASIL. The original reporting source was a state/territory health department. Additional information is not expected.

Write-up: Case received from the Health Authority (HA''s number PL-URPL-N259/2013) on 04 July 2013. A 5-year-old patient (gender not reported), with no reported medical history, had received intramuscularly the fifth dose of TRIPACEL (batch number C4007AK, expiration date: April 2014) in the left arm on 28 February 2013 at 9:30. On 06 March 2013 at 07:30, i.e 6 days post-vaccination, the patient presented severe injection site reaction at right arm expanding beyond the nearest joint, covering whole arm, lasting longer than 3 days, and allergic reaction: rash limited to certain areas of the skin also reported as rash in elbow area. At the time of reporting the patient was still treated at home. Reporter''s comments: "Oedema is still persisting." The HA coded "injection site reaction", "allergic reaction", "localized rash". The company coded "oedema". According to the Health Authority, the causal relationship between the events and the vaccine was considered as reasonable possibility. This case was considered as serious due to other medically important condition.

Write-up: Case received from the Health Authorities in a foreign country on 04-Jul-2013 under the reference number L201306-79 via the local site Sanofi Pasteur MSD. The primary reporter was a nurse. Case medically confirmed. A 13-year-old female patient experienced a localised oedema, difficulty in breathing and generalised erythema after she had received the first dose of GARDASIL (batch number H019462) subcutaneously on 06-May-2013. The patient had a family history of multiple allergies in her mother and her sister. She had a personal history of asthma (controlled) and several allergies including allergy to mucolytics and penicillin. She had experienced allergic rash after administration of ATARAX and BRUFEN. She was also allergic to spinach, French garlic, hazelnut, citrus, strawberry and seafood with the same cutaneous reactions. She was taking concomitant medication for asthma inhaled in SOS on an unknown start date. The localised oedema began shortly after vaccination and measured 2 cm in diameter. Difficulty in breathing and erythema occurred 8 hours and 12 hours post-vaccination respectively. She experienced no other manifestations. Difficulty in breathing resolved in a few minutes after the beginning of the events. Oedema and erythema lasted about 4 days. The patient received corrective treatment with inhaled bronchodilators and desloratadine in a dosage of 5 ml 6/6 hours for 3 days. The reporter did not suspect quality problems. The patient recovered. The Health Authorities assessed the causal relationship between the reported reactions (difficulty in breathing, generalised erythema) and vaccination as possible and between localised oedema and vaccinations as probable, according to the global introspection. The reporter assessed the causal relationship between the reported reactions and vaccination as probable according to an unknown assessment method.

Write-up: This case was reported by a physician via a regulatory authority (V13000419) and described the occurrence of contracture of joint of shoulder region in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 25 February 2013, the subject received 3rd dose of CERVARIX (intramuscular, left deltoid. on 25 February 2013 in the evening, less than one day after vaccination with CERVARIX, the subject experienced pain in joint involving shoulder region and brachialgia. On 26 February 2013, the symptoms still persisted. Therefore the subject visited an emergency outpatient department. In March 2013, 3 months after vaccination with CERVARIX, the subject experienced arm pain and injected limb mobility decreased. The subject was diagnosed with contracture of joint of shoulder region. The regulatory authority reported that the events were disabling. The subject was treated at the department of orthopaedics. At the time of reporting the events were unresolved.

Write-up: This case was reported by a physician via a regulatory authority (# V13000415) and described the occurrence of perceptual disturbance in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 25 July 2011, the subject received 1st dose of CERVARIX (intramuscular, left deltoid). Lot number not provided. In August 2011, one month after vaccination with CERVARIX, the subject experienced perceptual disturbance, numbness in left fingers, which recently spread to the right fingers and the right-sided scalp. No abnormality was found in the consultation. On 2 September 2011, the subject received 2nd dose of CERVARIX (intramuscular, right arm). Lot number not provided. In November 2011, the subject underwent detailed examination such as computerized tomography (CT) and magnetic resonance imaging (MRI) in 2 hospitals, but no abnormality was found. The subject was informed that the cause of the numbness was unknown. Approximately in March 2012, numbness improved. On 16 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, left arm). Lot number not provided. In May 2013, numbness of the fingers recurred (which was more prominent in the left fingers than the right fingers). The subject also had attacks of weakness in the peripheral region from the left elbow. On 13 June 2013, the subject was referred to the department of neurology of a hospital. The subject was under detailed examination at the moment. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR # 320872) concerning a 13 year old female patient. The patient''s medical history included allergy to KEFLEX and idiopathic anaphylaxis with shellfish. On 27-MAY-2013, the patient was vaccinated with a second dose of intramuscular GARDASIL (dose and lot number were not provided). On 27-MAY-2013, 30 minutes later the patient felt faint and had a rash on the arm. Lips and throat were hot. The patient self-administered ZYRTEC. Ambulance was called and the patient was transferred to hospital, was observed and discharge. On 27-MAY-2013, the patient recovered from the adverse events. The adverse events were possible related to GARDASIL by the reporter. The original reporting source was State/Territory health department. Additional information is not expected.

Write-up: Initial and follow up information has been received from a physician concerning a 13 year old female patient with juvenile idiopathic arthritis who on 25-JUL-2012 was intramuscularly vaccinated with the first dose of GARDASIL (Lot number 9QN03R, dose not reported). Other concomitant medication included methotrexate, HUMIRA and CELECOX. The patient had an underlying disease of juvenile idiopathic arthritis and juvenile idiopathic arthritis was recovering with adalimumab (genetical recombination), methotrexate and CELECOX. On 25-JUL-2012, the patient was vaccinate with the first dose of the vaccine. Around August 2012, a month after the first dose, arthritis was aggravated with the change of matrix metalloproteinase (MMP) from 32 to 116 (NR: 17-59) and MRI finding of synovitis aggravation. While the patient complained of increase of pain, the vaccine was continued on request of herself or her parents. On 19-SEP-2012, the patient was vaccinated with the second dose of the vaccine (Lot number (9QN04R). After the second dose, the patient complained of increase of pain again. In addition, on an unspecified date, the finding of MRI showed aggravation and CRP was increased. In November 2012, the patient received steroid temporally. On 01-JUL-2013, the patient was recovering from juvenile idiopathic arthritis aggravation gradually. Comment: The physician considered the causality as unknown while the causality could not be ruled out. As her mother had experienced cervix cancer, she might have a risk. Therefore, she, her mother and her grandmother requested the third dose. The reporting physician considered that the juvenile idiopathis arthritis aggravated was serious due to other important medical event. The reporting physician felt that the relationship between juvenile idiopathic arthritis aggravated and GARDASIL was unknown. Additional information is not expected.

Write-up: This case was received from the health authority on 12-Jul-2013. GB-MHRA-ADR 2166575. This case is medically confirmed as it was reported by a pharmacist. A 13 year old female (weight: 57kg) patient received on 12-Mar-2013 an injection of GARDASIL, (batch number not reported) intramuscularly, dose and site of administration not reported and on 15-Mar-2013 the patient experienced nausea, blurred vision, dizziness, rash, severe headache, lasting 2.5 weeks. She attended A&E twice and also the GP six times. The patient already received a pervious dose of GARDASIL in the past. The patient fully recovered on an unreported date. The MHRA considered that case serious due to be medically significant as the symptoms lasted over 2 weeks.

Write-up: Initial information has been received from a physician via PMDA concerning a 13 years old female patient. Orthostatic dysregulation was stated in the medical history interview as a point to remember on the patient. The patient had a family history of migraine (her father and mother) and hypotension (her father). In the afternoon 16-DEC-2011, the patient received the first injection of GARDASIL (batch # 9QN01R, also reported as 9QN02R) (injection site, dose not provided) intramuscularly. Her body temperature before the vaccination was 36.5 C. In the afternoon 13-FEB-2012, the patient received the second injection of GARDASIL (batch #9QN02R, lot#0108AA) intramuscularly (injection site, dose not provided) in the afternoon. Her body temperature before the vaccination was 36.8 C. No concomitant medication was reported. Since April 2010, the patient had been visiting the department of pediatric of another hospital as an outpatient for orthostatic dysregulation, chronic headaches, etc. Around February 2012, headache, queasy, vomiting, sleepiness and generally unwell developed in the patient. On 14-FEB-2012, one day after the second vaccine, the patient had felt headache and pain in shoulder strongly, but she went to school after taking loxoprofen (painkiller). On 22-FEB-2012, the headache and queasy became severe, and the patient visited the reporter''s hospital as an outpatient. Blood and imaging tests were performed, and the patient was to be allowed followed up with medication as aggravation of orthostatic dysregulation. From 14-MAR-2012 to 18-MAR-2012, the patient was hospitalized because of worsening of abdominal symptoms, physical decondition and headache (first hospitalization). These symptoms got better and worse thereafter, Around May 2012 (also reported as June 2012), the patient started to skip school because of worsening of headache, queasy, etc. From 09-MAY-2012 to 12-MAY-2012, the patient was hospitalized (second time). In June 2012, the symptoms were worsened. The patient told that sumatriptan succinate was ineffective, loxoprofen was effective a little and ibuprofen was low in effectiveness; she had orally been receiving Hange-byakujutu-tenmato (Chines herbal medicine). On 21-JUN-2012, she was depressed. On 22-JUN-2012, the patient visited the reporter''s hospital. From 22-JUN-2012 to 25-JUN-2012, the patient was hospitalized (third time) and underwent close examinations. (Examination results) No marked abnormality was found in the imaging or biochemistry. Acidum lacticum, pyruvic acid and amino acid analysis was normal. (Clinical course during hospitalization) The patient was closely watched with transfusion with cyproheptadine hydrochloride hydrate, amezinium metilsulfate (orally), loxoprofen (as needed). On 22-JUN-2012, the day the patient was admitted to the hospital, the patient was watching TV sitting on the bed, eating snacks and chatting with others pleasantly in the afternoon. On 23-JUN-2012, the patient was sleeping all the time in the morning. On 24-JUN-2012, drip infusion was discontinued because the patient was energetic. On 25-JUN-2012, the patient left the hospital cheerfully. The patient had been followed up as an outpatient since then. On 10-NOV-2012, frequency of headache was increasing probably because of the patient''s bad habit (sleeping, diet, etc.) those days. On 20-NOV-2012, the patient showed no response at all in the morning when the patient''s mother went into the patient''s room, and her mother called the outpatient department of the reporter''s hospital. It was considered to be transient consciousness clouding. From 20-NOV-2012, to 10-DEC-2012, the patient was hospitalized (fourth time) for headache, close examinations and to improve generally unwell through improvement of daily habit. (Status at admission) The patient''s consciousness was clear, and there was not neurological abnormality. Mild redness of pharynx was observed. Imaging test results were all normal except for mild bronchitis. (Cli

Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2012051922DE-PEI-PEI2013039648) and described the occurrence of sudden severe abdominal pain in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concomitant medication was not reported. On 19 June 2013 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown). Approximately 14 days post vaccination with CERVARIX, on 03 July 2013, the subject experienced sudden severe abdominal pain, followed by syncope; followed by headache, leg paresthesia and muscle weakness. The subject was hospitalised for an unknown period of time. Diagnosis was confirmed by normal magnetic resonance imaging (MRI) and normal C-reactive protein (CRP). The results from cerebrospinal fluid (CSF) test were pending. Headache and leg paresthesia lasted several days: After about 7 - 8 days, on 09 July 2013 to 10 July 2013 (date of reporting), all events were resolved. No further information will be available.

Write-up: This case was reported by a physician and then by the regulatory authority (V13000460) and described the occurrence of femoral nerve palsy in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included a mild intellectual disability attribuable to Prader-Willi syndrome. The subject was walked with crutches. On 24 September 2011 and 29 October 2011, the subject received 1st and 2nd doses of CERVARIX (intramuscular, left and right deltoid respectively). On 2 April 2012, the subject received 3rd dose of CERVARIX (intramuscular, left deltoid). On 29 January 2013, 10 months after vaccination with CERVARIX, the subject experienced painful arms and pain in the right thigh. The subject had numbness of the left fingers and felt dizzy (especially when standing up). On the next day, she experienced swaying feeling, vertigo and eye pain. On 31 January 2013, the subject experienced heaviness of head. On 21 May 2013, right femoral palsy and right hand paralysis (reported as arm paralysis) as well as diplegia of upper limbs developed but the symptom of the left upper limb improved in the evening, and was considered as resolved with sequelae as the subject was not able to open the right hand anymore. On 25 May 2013, the subject had painful right forearm. On 26 May 2013, the subject also experienced astasia and weakness of right lower extremity. The subject was admitted to hospital but the causes of symptoms were unknown. On 08 June 2013, the subject was discharged from the hospital, the pain in the right thigh persisted. In June 2013, vertigo, swaying feeling, painful arm and pain in the thigh were reported as improved. The symptoms of the right hand improved in the middle of the month of June but the subject was able to lift chopsticks (grip strength of the right hand was 5.1 kg; and 21 kg for the left hand). At the time of reporting, the subject had no more pain, the weakness of the right lower extremity persisted, the outcome of the rest of the events was unspecified.

Write-up: This case was reported by physician via a regulatory authority (# V13000446) and described the occurrence of generalized pain in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 22 May 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). Before vaccination, subject''s body temperature 36.8 Deg. C. On 7 November 2012, 6 months after vaccination with CERVARIX, the subject experienced abdominal pain on the left side. In November 2012: The subject visited a hospital. In February 2013, the subject regularly visited the reporter''s department with complaints of gastralgia, abdominal pain, and numbness. The pains could be controlled with oral treatment with stomach medicine and an analgesic. In June 2013, the subject started to complain strongly of generalised aching. At the subject''s visit to the hospital in June 2013, the reporting physician was informed that the subject had occasionally complained of the gastralgia and visceral pain to the subject''s mother since approximately 1 year before and that the subject''s mother had not been very concerned about the symptoms at that time. The pains gradually intensified thereafter, and the subject frequently complained of the visceral pain and bone pain in the entire body in June 2013 and felt strong anxiety. The subject was hospitalised for 1 week and was observed. The symptoms other than the gastralgia had subsided during the hospitalisation but were aggravated again after the discharge from the hospital. At the time of reporting, the events were unresolved. The regulatory authority reported that the causal relationship between generalised aching, gastralgia and malaise, and vaccination with CERVARIX was unassessable.

Write-up: This spontaneous report as received from a physician via the agency (agency reference # PL-URPL-N651/2013) refers to a 13 years old male patient. On 08-MAY-2013 the patient was vaccinated with M-M-RVAXPRO (lot # H010334, Exp April 2014), 0.5 ml, intramuscularly. Other suspect therapies included TD-PUR (Batch# 059081C, Exp May 2015) 0.5 ml, intramuscularly. On reporting form of post-vaccine reaction other than BCG were noted following adverse events: non febrile seizures, hypertonia, RR 130/80, ASM 80/minute, hypotonic-hyporesponsive episode with loss of consciousness, arthralgia. In narrative part of reporting form physician reported: up to 5 minutes after vaccination, while patient was sitting faint went into 2-3 seconds incident of seizures (non-febrile), stress of the body with bend to the back, with urination. The symptoms have resolved without treatment with complete return of consciousness while patient was in horizontal position with raised legs. Observation in clinic for about 1 hour- without symptoms with RR 13/80, AMS 80/minute during incident and RR 110/80 and ASM 80/minute when patient was leaving on his own. Due to lack of symptoms patient''s mother decided not to observe child at hospital. On the following day about 24 hours after vaccination- urticaria, recovered after Calcium i.v. From 12-MAY-2013, hypertonia of lower limbs with knees and thighs pain (arthralgia) on 13-MAY-2013 referral to pediatric neurology department. According to reporting form reaction occurred on 08-MAY-2013 at 12:15. Medical outcome: full recovery. Sender''s comment: Muscle and joints pain are expected reaction after both TD-PUR and MMRVAXPRO. Urticaria is reaction expected for M-M-RVAXPRO and unexpected for TD-PUR. Whereas hypertonia, increased blood pressure, loss of consciousness and involuntary urination are for both vaccines unexpected reactions (involuntary urination could be an effect of loss of consciousness). WHO database since 2010 noted 6 cases of joint pain, 37 cases of loss of consciousness, 12 cases of hypertonia and 26 cases of seizures after M-M-RVAXPRO and 7 cases of joint pain, 1 case of loss of consciousness and 1 case of seizures for TD-PUR. These are known reactions. Temporal relationship suggests causal relationship. There was already reported hypotonic hyporesponsive episode after this batch number of M-M-RVAXPRO. All adverse events were considered as medically significant by the health authority. Additional information is not expected.

Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-EYC 00102332) and described the occurrence of alopecia totalis in a 13-year-old female subject who was vaccinated with HPV vaccine. Concurrent medications included cetirizine hydrochloride. On 10 October 2012 the subject received unspecified dose of HPV vaccine. On 22 April 2013, the subject received the ''last'' dose of HPV vaccine. On 29 April 2013, 7 days after the last vaccination with HPV vaccine, the subject experienced alopecia totalis. A blood test came back as normal. The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved. The consultant diagnosed a return of the alopecia most likely triggered by the immunisation although the causality was reported as unknown. Verbatim Text: Alopecia Areata totalis - autoimmune condition when immune system is triggered by something and overreacts and attacks hair follicles. Approximately 1 week after last immunisation, hair began to fall out in large amounts. Visited GP to rule out other causes for hair loss - blood tests done. When test came back normal she was referred to a consultant dermatologist. The consultant diagnosed a return of the alopecia most likely triggered by the immunisation. She had to take prednisolone 5mg for 3 weeks. She has lost most of her hair on her head. She is now on steroids for 3 days every other week and applying ELOCON scalp lotion and ETRIVEX shampoo daily. So far she has lost most of her scalp hair. Seek Advice Details: Her hair started falling out at a significant rate, bald patches appearing. Seeked doctors advice to check if any other cause for hair loss, when other reasons ruled out she was referred to a consultant.

Write-up: This case was reported by a physician and described the occurrence of high-grade squamous intraepithelial lesion in a 19-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 13 February 2008, 2008 and 13 August 2008 the subject received 1st dose, 2nd dose and 3rd dose of CERVARIX (unknown route and site of injection). In February 2013, 5 years after vaccination with CERVARIX, the subject experienced first colpitis and was diagnosed with high-grade squamous intraepithelial lesion. On 11 June 2013, a pap biopsy was performed and the histological tests - results revealed mucosis from junctional area of cervix with plaques of squamous metaplasia mostly grade CIN 1, in minute section grade CIN 2. Immunochemical investigation revealed positivity p16 oncoprotein in the lower third of mucosis, in some places in the lower two-thirds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the outcome of the events was unspecified. The physician considered the events were almost certainly related to vaccination with CERVARIX.

Write-up: This case was reported by a physician and described the occurrence of a possible complex regional pain syndrome in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In March 2013, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site; lot number not provided). Around May 2013, 2 months after vaccination with CERVARIX, the subject experienced nonspecific symptoms: urticaria and multiple pains. The pains appeared to migrate. On 2 June 2013, 3 months after vaccination with CERVARIX, the subject experienced malaise. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 22 July 2013: This case was upgraded to serious. Concurrent medical conditions included epilepsy. Historic vaccination included CERVARIX; GlaxoSmithKline; intramuscular; given on August 2012 and October 2012. On 29 March 2013, the subject received 3rd dose of CERVARIX. On 5 May 2013, 37 days after vaccination with CERVARIX, the subject was admitted to hospital for urticarial where he was treated with an oral steroid. On 07 May 2013, the urticaria improved, and the subject was discharged from the hospital. On 08 May 2013, the subject visited the reporter''s hospital for the first time with complaints of face swelling and pain. The subject presented with pain and tenderness in both sides of the head, lower jaw, the back of the head, around the arms, and the back rib area. Adverse drug reactions caused by the oral steroids were suspected, and a drug for headache was prescribed. No abnormalities were noted in blood tests, blood plasma tests, general biochemical tests, and inflammatory reactions. The subject was euthyroid. On 16 May 2013, 48 days after vaccination with CERVARIX, the subject revisited the reporter''s hospital. The subject presented with urticaria in the nighttime and queasy persisting all day. The pain improved. An antihistamine and an analgesic were prescribed. In May 2013, 2 months after vaccination with CERVARIX, the subject experienced arthralgia. On 02 July 2013, 65 days after vaccination with CERVARIX, the subject experienced malaise. He revisited the reporter''s hospital where the complex regional pain syndrome (CRPS) was suspected. At an unspecified time after vaccination with CERVARIX, the subject experienced the subject experienced physical deconditioning, lower abdominal tenderness and migraine. At the time of reporting the outcome of pain, swelling of face, facial pain, tenderness, physical deconditioning, lower abdominal tenderness, migraine, lower jaw tenderness, tenderness of arm, tender back, arthralgia, headache, urticaria and queasy was unspecified. The complex regional pain syndrome and malaise were unresolved. The physician considered the complex regional pain syndrome was possibly related to vaccination with CERVARIX. Related to the effect of the steroid administered for treatment of the urticaria at another hospital and migraine.

Write-up: This case was reported by a physician via a regulatory authority (V13000466) and described the occurrence of ulcerative colitis in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included iron deficiency anemia. Historic medications included Ferromia. Concurrent medications included Fero-gradumet. Subject''s body temperature before the vaccination was 35.5 Deg. C. On 9 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). On 10 March 2012, the subject had queasy and difficulty in orally receiving his treatment for iron deficiency anaemia: Ferromia tablet. Accordingly, the medication was switched to Fero-Gradumet. On 11 March 2012, 2 days after vaccination with CERVARIX, the subject experienced exertional dyspnea and asthma-like attack during the club activity, for which she received inhalation treatment at hospital. The symptom improved. On 31 March 2012, 22 days after vaccination with CERVARIX, the subject experienced bloody stools. On 23 April 2012, 45 days after with CERVARIX, the subject was admitted to the hospital for aggravated anaemia. On 09 May 2012, the subject was hospitalised for suspected ulcerative colitis. A diagnosis of ulcerative colitis was made, for which she received treatment. On 25 June 2012, the subject was discharged from the hospital. On 16 July 2013, the exertional dyspnea, bloody stools improved. At the time of reporting the outcome of aggravated anaemia was unspecified and the outcome of ulcerative colitis was unresolved.

Write-up: This case was received from the health authority on 22-Jul-2013. GB-MHRA-ADR 22176810. This case is not medically confirmed as it was reported by a consumer (Also reported as other health). A 13 year old female patient (weight: 57.15 kg), who already received a dose of HPV (manufacturer unknown) on 10-Oct-2012, received another case of HPV (manufacturer unknown, batch number not reported), dose, site and route of administration not reported on 22-Apr-2013. The patient was concomitantly treated with cetirizine hydrochloride, 1 dosage form once a day. On 29-Apr-2013, the patient experienced alopecia areata totalis, hair began to fall out in large amounts, bald patches appearing. The patient visited a general practitioner to rule out other causes for hair loss. Blood tests were done and came back normal. She was then referred to a consultant dermatologist. The consultant diagnosed a return of the alopecia (though alopecia was not coded in patient''s past medical history by agency) most likely triggered by the immunisation (autoimmune condition when immune system is triggered by something and attacks hair follicles). She had to take prednisolone 5 mg for 3 weeks. She had lost most of her hair on her head. At the time of reporting, the patient was on steroids for 3 days every other week and applying ELOCON scalp lotion and ETRIVEX shampoo. So far, she had lost most of her scalp hair. At the time of reporting, the patient was not recovered. The agency considered that case serious due to be medically significant.

Preexisting Conditions: No relevant medical history; no medical history of seizures, movement disorders, head injury, other CNS conditions, cerebral palsy, neurological handicap or congenital abnormality, diabetes, renal failure or alcohol or drug abuse; no sign of a neurological lesion or infection which might have been the cause of the seizure; no intake of medication which is known to reduce the seizure threshold

Write-up: This case was reported by a physician and described the occurrence of convulsion in a 13-year-old male subject who was vaccinated with HAVRIX 720 (GlaxoSmithKline). The subject had no relevant medical history. On an unspecified date, the subject received a 1st dose of HAVRIX 720 (batch, route and injection site unknown). After vaccination the subject experienced severe fatigue and nausea which resolved in unspecified times. On 03 July 2013, the subject received a 2nd dose of HAVRIX 720 (batch, route and injection site unknown). In doctor''s practice, the subject had convulsion which resolved spontaneously after about 20 seconds. This case was assessed as medically serious by GSK. At the time of reporting, the events were resolved. Causality assessment was not provided. Upon follow-up received on 22 July 2013: The subject weighed 47.4 kg. The subject had no medical history of seizures, movement disorders, head injury, other CNS conditions, cerebral palsy, neurological handicap or congenital abnormality, diabetes, renal failure or alcohol or drug abuse. He did not receive any medication which is known to reduce the seizure threshold. There was no sign of a neurological lesion or infection which might have been the cause of the seizure and no abnormal serum electrolytes. After vaccination the subject had a feeling of malaise with injected arm pain followed by a myoclonus of upper limbs lasting for a few seconds while he was in sitting position. The subject was somnolent with headache, pallor and nausea for 15-30 minutes. During this episode, the subject had no urine or fecal incontinence. At the time of reporting, the events were resolved. Causality assessment was not provided.

Write-up: Case received from the Health Authorities on 22-Jul-2013 (reference no. PEI2013041445). Case is medically confirmed. A 10-year-old female patient received the third dose of GEN H-B-VAX K (lot-no. R1430-1) into the upper arm on 29-May-2001. The patient received the first dose of PRIORIX (GSK, lot-no. 690174PD) into the upper arm and the first dose of ENCEPUR (Novartis Vaccines, lot-no. 061031A) into the upper arm on 16-Mar-2004 at the age of 13. On an unspecified date the patient developed compulsions, insomnia and iron deficiency anemia. In 2005 the patient developed Hashimoto''s disease and hypothyroidism. Blood test and examination of the thyroid were performed to confirm diagnoses (results not reported). At the time of reporting, the patient had not recovered and it was reported, that the patient was permanently disabled. The patient received D1 of GEN H-B-VAX K (lot-no. R1430-1) on 16-May-2000 and D2 (GEN H-B-VAX K (lot-no. R1430-1) on 04-Jul-2000. Toleration was not reported.

Write-up: This case was reported by a physician via a regulatory authority (# V13000486) and described the occurrence of chronic fatigue syndrome in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 23 August 2011, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site). On 24 August 2011, 1 day after vaccination with CERVARIX, the subject experienced malaise. Even after that, the malaise persisted, and the subject mainly went to the school clinic while she was at school. At an unspecified date, after vaccination with CERVARIX, the subject experienced walking difficulty. On 24 October 2011 till 31 October 2011, the subject was hospitalised to the reporter''s hospital and from 31 October 2011 till 10 November 2011, the subject was admitted to a another hospital, where a detailed examination showed no problems. At an unspecified date, a diagnosis of chronic fatigue syndrome was made. At the time of reporting the outcome of the events was unspecified.

Write-up: This case was reported by a physician via a regulatory authority (V13000513) and described the occurrence of pain in right upper arm in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Before vaccination, her body temperature was 36.5 deg C. On 15 March 2012 the subject received 3rd dose of CERVARIX (intramuscular, left deltoid). On 26 October 2012, 7 months after vaccination with CERVARIX, the subject experienced pain and weakness in right upper arm. The regulatory authority reported that the events were disabling. The subject visited the hospital several times. On 6 December 2012, a MRI was done and was normal. At the time of reporting the events were unresolved. On 26 July 2013, the subject experienced severe pain when moving the right thumb and was not able to use the right arm.

Write-up: This case was reported by a physician and described the occurrence of tremor in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included retinopathy of prematurity. Concurrent vaccination included 1st and 2nd dose of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given on May 2012 and on an unspecified date. In November 2012, the subject received 3rd dose of CEVARIX (intramuscular, unknown injection site, batch number not provided). On 30 July 2013, 8 months after vaccination with CERVARIX, the subject experienced tremor of the right hand and both feet. On 1 August 2013, in the morning, the subject was hospitalised. Nuclear Magnetic Resonance Imaging and electroencephalogram were performed to detect whether the event was attributable to other diseases but results were not provided. At the time of reporting, the event was unresolved.

Write-up: Initial report received from a healthcare professional on 01 July 2013. A 13-year-old female patient; who had no significant medical history and whose concomitant medications were not reported, had received first primary dose of MENACTRA (lot number: not reported) intramuscularly in left arm on 29 June 2013. On 30 June 2013; 24 hours after vaccination, the patient developed swelling in the left index finger. Left wrist was also swollen and painful on movement. Third left finger was starting to swell and the patient had tingling in fingers. There was no swelling or pain at the vaccination site. The patient''s complimentary investigations were not reported and the patient received ibuprofen (antalgics and anti-inflammatory) as corrective treatment. The outcome of the events was not reported. Relationship as per reporter: Yes. Documents held by sender: None.

Write-up: This pregnancy follow up case was received from Health Authority on 07-Jul-11 under the reference number 2011-004740. This case is medically confirmed. A 13 year old female patient with an unreported medical history and concomitant medication received the first dose of a GARDASIL, (NM46680) route and site not reported on 06-Jun-10 and subsequently received the second dose of a GARDASIL on 17-Dec-10. The patient was due to received the third dose on 20-May-11 but this dose was not given because the patient had a baby the previous day on 19-May-11. No further information was reported. The IMB considered the pregnancy to be serious due to other medically important condition which required intervention. Follow up received from the IMB on 29-Aug-11. According to the reporter the duration of the patient''s pregnancy was 39 weeks. The weight of the infant was 2.910 kilograms. There were no complications at birth, a normal spontaneous vaginal delivery. The mother is breast feeding and the baby is doing fine so far. Follow up received from the IMB on 06-Aug-2013: The IMB coded the event of no adverse reaction to better capture the outcome of the pregnancy.

Write-up: This case was reported by the foreign Regulatory Authority (reference MA20131229) and described the occurrence of multiple sclerosis in a 19-year-old female subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). The subject''s medical history and concomitant medications, if any, were not specified. Between 27 August 1996 and 10 March 1997, the subject received three primary doses of ENGERIX B pediatric (batch number, route and injection site unknown) through mandatory vaccination program at school. In February 2003, i.e. 06 years after vaccination with ENGERIX B pediatric, the subject presented with sensory disorder and lower limbs giving way. In April 2003, the patient experienced lower limbs paresthesia, walking disorder when she went straight and uncontrollable laughing fit. Sensory disorder remained. On 19 April 2003, multiple sclerosis was diagnosed. Later on, the subject experienced second flare-up with facial paralysis, optic neuritis, loss of balance and sensory loss. Paresthesia in lower and upper limbs remained. Loss of concentration and memory disorder was reported. The subject was followed-up for remittent multiple sclerosis. The regulatory authority reported that the event was disabling. At the time of reporting multiple sclerosis was unresolved. According to the agency, based on the foreign method of assessment, multiple sclerosis was dubiously related to ENGERIX B pediatric.

Write-up: Case was received from a physician via the Health Authorities on 13-Aug-2013 under the reference number (FI-FIMEA-20130862). Case is medically confirmed. A 13-year-old female patient, with a medical history of Raynaud''s syndrome and common variable immunodeficiency, received a dose of PNEUMOVAX23, lot-no. not reported) via intramuscular route into the left upper arm on 26-Jun-2013. One day later, on 27-Jun-2013, the patient developed pain throughout the body, headache, fever up to 40.5 and an intense vaccination site reaction. C-reactive protein was 140. The patient was hospitalised from 28-Jun-2013 to 02-Jul-2013. The patient had recovered from fever after 3 days, from vaccination site reaction after 4 days and at the time of reporting the patient had recovered completely.

Write-up: Case was received from the Health Authorities on 14-Aug-2013 (reference no. PEI2013046170). Case is medically confirmed. A 13-year-old female patient received the second dose of GARDASIL (lot-no. not reported) IM on an unspecified date in Sep-2011. Following the vaccination, the patient developed fever and a severe general reaction lasting for one week. Two months after vaccination, the patient experienced poor concentration and general ill feeling. Patient missed school on a regular basis. Eight months after vaccination, the patient developed tremor, syncopes and tonic-clonic jerks in terms of dissociative seizures requiring several hospital stays. At the time of reporting to local HA on 21-Mar-2013, the outcome was unknown. D1 of GARDASIL (lot-no. not provided) given in May-2011 was well tolerated.

Write-up: This case was received from the health authority in a foreign country on 23-Aug-2013. GB-MHRA-ADR 22214093. This case is not medically confirmed as it was reported by a consumer. A 13 year old male patient (weight: 31.75 kg) with no medical history reported, received on 07-Aug-2013 an injection of measles, mumps and rubella vaccine (MFR UNK, batch n. and site of administration not reported) intramuscularly and on 13-Aug-2013, he presented abdominal pain and very high temperature. At the time of reporting the patient had not recovered. The MHRA considered that case serious due to disability/incapacity.

Write-up: Information has been received from a physician via the agency concerning a 13-year-old female patient. According to the pre-vaccination interview about underlying disease, allergy, past history of vaccination/disease during recent one month, concomitant medications, ADR history and status of growth, the patient had no problem. The patient had no family history. Her body temperature before the vaccination was 36.9 C. On 19-JUN-2012 at 11:40, the patient received the syringe-type first GARDASIL intramuscular injection drug (Lot number 9QN03R) (dose was not provided). No concomitant medication was reported. On 02-JUL-2012, the patient had pyrexia of 39 C at 8:00, and pyrexia of around 39 C continued thereafter. Possibility of infection was excluded in blood tests, and collagen disorder was also denied. MRI, contract CT and PET also denied the malignant tumor. No abnormality in hormone system. An endoscope revealed no abnormality on Behcet''s disease or mixed collagen disorder. The pyrexia was judged to be psychogenic pyrexia, and her clinical course was being followed up. On 23-AUG-2012, the patient was admitted to hospital. In autumn of 2012, the patient''s body temperature had been 38 C. On 27-SEP-2012, the patient received the second dose of GARDASIL intramuscular injection drug (lot No. 9QN06R) (dose was not provided). On 28-SEP-2012, the patient was discharged from hospital. At the end of December 2012, the temperature went down to 37 C. On 31-JAN-2013, the patient received the third dose of GARDASIL intramuscular injection drug (lot No. 9QN07R) (dose was not provided). Around March 2013, the patient had convulsion-like myoclonus during night sleep and weakness of right side of body in the daytime. Results of head MRI were normal, while sharp waves were observed at the right parietal region. During an observation period, the patient had had the myoclonic-like involuntary movements during sleep-time and the wakeful weakness in the daytime continuously. In July 2013, brain imaging showed normal brain waves, and also normal results in MRI of head, thoracic spine and neck. Valproic acid was administered for suspected epilepsy but did not improve her conditions. MRI performed for possible spinal myoclonus, and it was normal. As of 16-AUG-2013, the patient had not recovered from the myoclonic-like involuntary movements or pyrexia. Clonazepam had been administered for the myoclonic-like involuntary movements. The outcome of the weakness of right side of body was unknown. Reporter''s comment: The patient had pyrexia of 39 C of unknown origin since 02-JUL-2012 after the first vaccination on 19-JUN-2012. At the beginning, I had never thought that the event was due to the GARDASIL, and I judged that it was psychogenic pyrexia from the head examination results. I then came to think that the relation to the vaccine could completely not be denied from the fact that the myoclonic-like involuntary movements appeared in March 2013 after the second and third vaccinations. The reporting physician considered that the causal relationship of the myoclonic-like involuntary movements and pyrexia to GARDASIL was unassessable, and also considered that other possible causes of the event were epilepsy, spinal myoclonus, psychogenesis, etc. The reporting physician did not assess the causal relationship of the weakness of right side body to the vaccine. The reporting physician assessed the myoclonic-like involuntary movements as serious (possible disability) (also reported as medically significant) and pyrexia as serious (possible disability (also reported as medically significant) and hospitalization). The reporting physician did not assess the seriousness of the weakness of right side of body. Remarks: Serious (possible disability) is entered as serious OME due to internal procedures. Additional information has been requested.

Write-up: This case was reported by a physician and described the occurrence of painful periods in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included 1st dose of CERVARIX (GlaxoSmithKline); (intramuscular, left deltoid) given on 27 August 2011 and 2nd dose of CERVARIX (GlaxoSmithKline); (intramuscular, right deltoid) given on 24 September 2011. On 25 February 2012, the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, left deltoid). On an unspecified date in July 2012, 5 months after vaccination with CERVARIX, the subject experienced painful periods, numbness in hand and headache. At the time of reporting, numbness in hand was resolved but painful periods and headache were unresolved.

Write-up: This literature marketed report as received from a other health professional via a journalist concerning a 13 year old female patient. Her personal medical history was remarkable only for common infections, rash due to pityriasis rosea treated and resolved several months before vaccination. Her family history revealed several members of the family with autoimmune diseases including systemic lupus erythematosus (SLE). On an unknown date, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient approached her general physician 3 weeks following the second dose of vaccination due to swelling of her index finger and a rash. During the following couple of months, she developed erythematous rash on her face, fever, periorbital edema, weight loss, malaise, fatigue, cervical, axillary and inguinal lymphadenopathy as well as mild anemia. She was referred to a rheumatologist who noted that she had a petechial rash, alopecia, leucopenia of 2100 cells per cubic millimeter and mild thrombocytopenia. Further evaluation documented seropositivity for antinuclear rate (ESR). The C-reactive protein (CRP) level was normal. On an unknown date, the patient was diagnosed with systemic lupus erythematosus (SLE). The patient was treated with hydroxychloroquine and prednisone. Despite therapy, disease progression was documented with the appearance of CNS (i.e. seizures) and kidney involvement. Renal biopsy was compatible with mesangial proliferative glomerulonephritis, class II lupus nephritis. Thus, therapy was enhanced with high-dose steroids, cyclophosphamide, as well as antiepileptic medications. Under this therapy, there was gradual remission of the SLE. The outcome of the events was reported as resolving. The reporter considered SLE to be related to GARDASIL. The relatedness for seizures was unknown. It was reported that the highest relative risk for an individual autoimmune event was for systemic lupus erythematosus (SLE). A casual link between HPV vaccinations and onset or relapse of SLE is plausible. Upon internal review, systemic lupus erythematosus (SLE) and seizures were considered as medically significant. This is one of the several reports from the same source. Additional information has been requested.

Write-up: Case retrieved from the literature on 02-SEP-13. Case medically confirmed. The abstract initially received on 02-MAY-2013 was described in linked case E2013-03484 which was updated with information of patient n. 1. The other 4 patients reports of the article were described in linked cases E2013-06723; E2013-06725; E2013-06726 and E2013-06727 (same vaccine, similar events, different patients). This case concerns patient n. 6: a 13-year-old female approached her general physician 3 weeks following immunization with the second dose of GARDASIL due to swelling in her index finger and a rash. During the following couple of months, she developed erythematous rash on her face, fever, periorbital edema, weight loss, malaise, fatigue, cervical, axillary and inguinal lymphadenopathy, as well as mild anemia. At this stage, she was referred to a rheumatologist who noted that she had a petechial rash, alopecia, leucopenia of 2,100 cells/mm3, and mild thrombocytopenia. Further evaluation documented seropositivity for ANA, anti-RNP, anti-Smith and anti-RO/SSA antibodies as well as low C3 and C4, elevated ESR. The CRP level was normal. The patient was diagnosed with SLE. Hydroxychloroquine and prednisone treatment was started. Despite therapy, disease progression was documented with the appearance of CNS (i.e., seizures) and kidney involvement. Renal biopsy was compatible with mesangial proliferative glomerulonephritis, class II lupus nephritis. Thus, therapy was enhanced with high-dose steroids, cyclophosphamide, as well as antiepileptic medications. Under this therapy, there was gradual remission of the SLE. Notably, her personal medical history was remarkable only for common infections and a rash due to pityriasis rosea treated and resolved several months before immunization. Her family history revealed several members of the family with autoimmune diseases including SLE. The case is closed. The authors mentioned that based on the current available data, a causal link between HPV vaccine and onset or relapse of SLE is plausible. Upon internal review the Company assessed the case as serious.

Write-up: This spontaneous report as received from a pharmacist via company representative refers to a 13 year old female patient. On an unknown date the patient was vaccinated with a first dose of GARDASIL (dose, strength, indication, route of administration not reported). On 09-SEP-2013 at around 10:00 AM (on an approximately 10:00 AM), the patient was vaccinated with second dose of GARDASIL (intramuscular, dose, strength, lot not reported). There was no concurrent conditions. After 1 hour from vaccination with GARDASIL (on an approximately 09-SEP-2013 at 11:00 AM), subject experienced fever and fever was raising in the evening (exact values and units not provided) had febrile delirium. Parent has cleaned subject''s body with water to make fever decreased and then subject was admitted in the hospital in the night of that day (09-SEP-2013). On the morning of 10-SEP-2013, subject was in the hospital and the event was resolving. Parent worried about the vaccination with GARDASIL, since the subject was healthy. The causality by pediatrician was not specified caused by vaccination with GARDASIL. It may be caused from other factors. The causality by gynecologist who was the consultant of vaccination with GARDASIL was not likely related to vaccination since subject has received second dose of GARDASIL, and no adverse event was reported for first dose of GARDASIL (date, dose, strength, indication, route of administration not reported). Pharmacist did not provide causality for GARDASIL. The parent worried and informed the hospital that the subject will receive third dose of GARDASIL in the hospital, not school for closely monitoring of adverse event in the hospital further. Additional information has been requested.

Write-up: This case was reported by a physician and described the occurrence of complex regional pain syndrome in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In April 2013, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, unknown injection site and batch number). On 20 August 2013, 4 months after vaccination with CERVARIX, the subject experienced pyrexia (39 Deg.C) and arthralgia. The subject visited a practitioner and received non-steroidal anti-inflammatory (NSAID). She was placed under observation. Generalised joint pains involving the hands, shoulders, knees and elbows persisted and did not improve. The subject was able to walk, but unable to attend physical education classes. On 22 August 2013, since no improvement had been observed in the symptom, she visited the reporter''s hospital and no traumatic injury including fracture was noted. The possibility of complex regional pain syndrome (CRPS) could also not be ruled out. At the time of reporting the events were unresolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 11 September 2013: Concurrent medical conditions included seasonal allergy. In April 2013, on the following day of the vaccination, the subject experienced pyrexia (39 Deg. C) and joint pains in both shoulders, both elbows, both hands, both knees, and both feet. On 22 August 2013, as the joint pains in the extremities did not improve, the subject visited the reporter''s hospital. The subject underwent tests for rheumatoid arthritis and systemic lupus erythematosus, which showed negative results. Radiography for the joints showed no fracture or no joint destruction. The subject began to receive other NSAIDs in place of the previous NSAIDs and was observed for a week, but NSAIDs were ineffective. On 29 August 2013, as NSAIDs were ineffective, the subject started to receive TRAMCET. The subject was hospitalised and the generalised joint pain was considered as disabling. Therefore, the case was upgraded to serious. At the time of reporting, the fever was resolved and the general joint pain was unresolved. The physician considered the events were related to vaccination with CERVARIX.

Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-EYC 00103623) and described the occurrence of seizure in a 13-year-old female subject who was vaccinated with HPV vaccine. On 21 June 2013 the subject received an unspecified dose of HPV vaccine. On 21 June 2013, the same day as vaccination with HPV vaccine, the subject experienced seizure and pain in legs and arms. The subject was hospitalised for 2 weeks. The subject was given an anti-epileptic drug to which she experienced adverse effects. The subject was reported to be "psychotic and in a very bad way". At the time of reporting the events were unresolved. Verbatim Text: My daughter has been having seizures and achy legs and arms. Please could you look at this as a matter of urgency as my daughter was an above targets pupil. My daughter''s dance school now refuse to let her in and she cannot do her beloved drama. My daughter has spent two weeks in hospital most of which she was put to sleep as no one knew what to do and what was happening. My daughter was then given an anti-epileptic drug which she had adverse effects to. My daughter was psychotic and in a very bad way. I''m now left with a 13 year old that was healthy and happy to a poorly teenager who needs my constant attention in case she takes a turn for the worse. No one can tell me if or when this is going to stop. I am at my wits end and am thinking about seeking legal advice as no one can or is willing to help me out.

Write-up: This case was reported by a physician and described the occurrence of cough in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In August 2013, in the middle of this month, the subject received first dose of CERVARIX (intramuscular, unknown site of injection and batch number). Ten minutes after vaccination with CERVARIX, the subject experienced cough and stumbling (difficulty in standing), for which the subject visited a hospital and received emergency treatment. On 13 September 2013, the subject received second dose of CERVARIX (intramuscular, unknown site of injection and batch number). On 13 September 2013, 20 minutes after the vaccination, the subject experienced cough. As the cough did not cease, ATARAX-P was administered. The cough ceased after the administration of ATARX-P, and the subject''s condition was stabilised with sleep. As the vaccination was performed in the evening, the subject was hospitalised for a night as a precautionary measure. The subject also presented with chest pain (which was considered attributable to the cough). It appeared that the subject presented with slight residual pain on the following day. The subject would revisit the hospital on 20 September 2013. At the time of reporting, the chest pain was improved and the outcome of difficulty standing was unknown. The physician considered that cough was related to vaccination with CERVARIX.